Adaptive Phage Therapeutics (APT) is a clinical-stage biotech advancing therapies to treat multi-drug resistant infections. We are on a mission to address today’s — and tomorrow’s — most challenging infections. We are looking for intelligent and motivated people to help us reach those goals.
The responsibilities of the Clinical Program Manager (unblinded) are geared toward supporting the protection and maintenance of the study blind. This role is structured to enable issue resolution, avoid accidental unblinding events, and mitigate regulatory risks. The role will liaise with blinded and unblinded staff to minimize potential errors and oversee investigational product supply and management. This position will manage all clinical supplies including ancillary supplies, and non-IP supplies. Responsibilities include creating & contributing to the development of study procedural documents and system development, oversight for activities regarding site pharmacy staff training, IP management, IP/dosing-related issues, unblinded Protocol Deviation (PD) escalation, and resolution, and monitoring pharmacy compliance with the protocol and study procedures (including unblinded monitoring visits). This position may support unblinded analyses and safety reviews and safety follow-ups and support eIND activities.
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required for this job. Duties, responsibilities, & activities may change at any time with or without notice.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job and will be available to the candidate upon request.
APT is an Equal Opportunity/Affirmative Action employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. APT seeks to diversify its work force and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Notice to Third-Party Recruiters/Staffing Agencies: Recruitment is managed through the Adaptive Phage Therapeutics Human Resources department. Resumes will only be accepted from staffing agency/recruiters if there is a signed contract in place. Recruiters are requested to not contact our hiring managers or employees directly to inquire about open positions or to present candidates. In the event a staffing agency/third-party recruiter submits a resume without a contract in place, the candidate submitted will be considered unsolicited and treated as if the candidate submitted their resume directly to Adaptive Phage Therapeutics, and no fee/payment will be paid. Recruiters interested in working with Adaptive Phage Therapeutics can submit their information to firstname.lastname@example.org and we will contact you if needed.